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Cell Therapy

Schwann Cell Therapy for Peripheral Nerve Injury

Phase 1
Waitlist Available
Led By Allan Levi, MD, PhD
Research Sponsored by W. Dalton Dietrich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings
Between the ages of 18 and 65 years at last birthday
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 5 years
Awards & highlights

Study Summary

This trial is studying whether autologous human Schwann cells can improve nerve function in people with severe nerve damage.

Who is the study for?
This trial is for adults aged 18-65 who have had a severe peripheral nerve injury with a gap of 5-10 cm between healthy nerve endings within the last year. It's not suitable for those unable to undergo an MRI, with conditions affecting sural nerve harvest, gaps over 10 cm, local cancer history, pregnant women, or those with certain diseases or substance abuse.Check my eligibility
What is being tested?
The study tests whether using one's own Schwann cells (ahSC) to repair damaged nerves can improve healing and function. Participants will receive ahSCs during surgery where their own nerves are used as grafts in areas like the sciatic nerve or brachial plexus.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection and pain at the extraction site. There might also be immune reactions since cells are being transplanted, although this risk is reduced by using the patient’s own cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a nerve injury with a gap of 5 to 10 cm between ends.
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I am between 18 and 65 years old.
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I have had a severe nerve injury in my arm or leg within the last year.
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I have had a severe nerve injury in my arm or leg within the last year.
Select...
I have a nerve injury with a gap of 5 to 10 cm between healthy ends.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with reported adverse events (AEs)
Number of participants with reported cell product culture test failure
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Secondary outcome measures
Change in muscle strength scale grade of affected limb muscles
Change in pain characteristics (location, intensity, and description)
Change in pain scores
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous human Schwann cellsExperimental Treatment1 Intervention
All participants will receive autologous human Schwann cells harvested from their own sural nerve.

Find a Location

Who is running the clinical trial?

W. Dalton DietrichLead Sponsor
6 Previous Clinical Trials
47 Total Patients Enrolled
The Miami Project to Cure ParalysisOTHER
5 Previous Clinical Trials
25 Total Patients Enrolled
Allan Levi, MD, PhDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

Autologous Human Schwann Cells (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03999424 — Phase 1
Peripheral Nerve Injury Research Study Groups: Autologous human Schwann cells
Peripheral Nerve Injury Clinical Trial 2023: Autologous Human Schwann Cells Highlights & Side Effects. Trial Name: NCT03999424 — Phase 1
Autologous Human Schwann Cells (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999424 — Phase 1
Peripheral Nerve Injury Patient Testimony for trial: Trial Name: NCT03999424 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals of this research endeavor?

"This trial's primary goal is to assess the number of adverse events (AEs) reported over a two-year period post-transplant. Secondary outcomes being evaluated include changes in pain scores as measured by the Douleur Neuropathique 4 questionnaire, alteration in pain characteristics such as location and intensity via a diagramatic representation, along with any variations in muscle strength grade for affected limb muscles assessed using the Medical Research Council scale."

Answered by AI

Has the FDA sanctioned autologous human Schwann cells as a viable therapy?

"Due to the limited clinical data associated with autologous human Schwann cells, its safety score was evaluated at 1."

Answered by AI

What are the eligibility requirements for participation in this clinical trial?

"This trial seeks 10 individuals, aged 18 to 65 who have had a peripheral nerve injury within the past year and present with 5-10 cm gaps between healthy nerve endings. Qualified candidates must also possess sciatic, brachial plexus or major upper/lower extremity injuries."

Answered by AI

Is the upper age limit for participation in this trial above 25 years?

"Conforming to the eligibility requirements of this clinical trial, participants must be at least 18 years old and no more than 65."

Answered by AI

Is there capacity within this experiment for additional participants?

"As per the information on clinicaltrials.gov, this study is not currently recruiting patients. The trial was posted on September 24th 2019 and last modified nearly three years later on November 22nd 2022. However, 13 other trials are presently looking for enrollees at present."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I suffered with a herniated disk and bulging disk while playing tennis. As a result I have peripheral neuropathy in both my feet.
PatientReceived no prior treatments
~2 spots leftby Sep 2025